An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth

Not Applicable

Completed

• Conditions: Stress; Anxiety; Depression; Posttraumatic Stress Disorder

• Registration Number: NCT02736136
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

This study aims to investigate the effects of an early intervention (joint observation and video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who have given birth to a very premature baby will be randomly allocated to either the early intervention or usual care whilst the infant is still hospitalized. Participants will be followed up at one month and six months. It is predicted that participants who received the early intervention will report higher maternal parenting self-efficacy than those who are not.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-13
• Study Start: 2016-08
• Primary Completion: 2020-02
• Study Completion: 2020-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

Inclusion Criteria

• Mothers of very preterm infants born between 28 and 32 weeks of gestation
• Infant aged up to 8 weeks

Exclusion Criteria

• Do not speak French sufficiently well to participate in assessments
• Have established intellectual disability or psychotic illness
• Infant too instable regarding hemodynamic or respiratory functioning (severe brady apnea, more than 30% oxygen)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perceived Maternal Parenting Self-Efficacy tool	1 month

Secondary Outcome Measures

Name	Time	Method
Posttraumatic Diagnostic Scale	1 month, 6 months
Perceived Maternal Parental Self-Efficacy tool	6 months
Infant Behaviour Questionnaire - Revised very short form	1 month, 6 months
Parental Stressor Scale: Neonatal Intensive Care Unit	1 month, 6 months
Mother-to-Infant Bonding Scale	1 month, 6 months
Emotional Availability Scale	6 months
Hospital Anxiety and Depression Scale	1 month, 6 months
Edinburgh Postnatal Depression Scale	1 month, 6 months
CARE-Index	6 months
Parental Stress Index - Short form	1 month, 6 months

Trial Locations

Locations (1)

Neonatology Service, University Hospital Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland